Klassic Tibial Insert, PS-Post, E-Link

GUDID 00814703016332

Tibial Insert, PS-Post, E-Link, Size 2, 16mm

TOTAL JOINT ORTHOPEDICS, INC.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 00814703016332
• NIH Device Record Key: f2e69f35-2385-4a9c-b851-a3befe249a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, PS-Post, E-Link
• Version Model Number: 5305.02.016
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)486-6070
• Email: udi@tjoinc.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703016332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183596

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00814703016332]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-24
• Device Publish Date: 2019-04-16

On-Brand Devices [Klassic Tibial Insert, PS-Post, E-Link ]

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• 00814703016608: Tibial Insert, PS-Post, E-Link, Size 6, 14mm
• 00814703016592: Tibial Insert, PS-Post, E-Link, Size 6, 13mm
• 00814703016585: Tibial Insert, PS-Post, E-Link, Size 6, 12mm
• 00814703016578: Tibial Insert, PS-Post, E-Link, Size 6, 11mm
• 00814703016561: Tibial Insert, PS-Post, E-Link, Size 6, 10mm
• 00814703016547: Tibial Insert, PS-Post, E-Link, Size 5, 16mm
• 00814703016530: Tibial Insert, PS-Post, E-Link, Size 5, 14mm
• 00814703016523: Tibial Insert, PS-Post, E-Link, Size 5, 13mm
• 00814703016516: Tibial Insert, PS-Post, E-Link, Size 5, 12mm
• 00814703016509: Tibial Insert, PS-Post, E-Link, Size 5, 11mm
• 00814703016493: Tibial Insert, PS-Post, E-Link, Size 5, 10mm
• 00814703016479: Tibial Insert, PS-Post, E-Link, Size 4, 16mm
• 00814703016462: Tibial Insert, PS-Post, E-Link, Size 4, 14mm
• 00814703016455: Tibial Insert, PS-Post, E-Link, Size 4, 13mm
• 00814703016448: Tibial Insert, PS-Post, E-Link, Size 4, 12mm
• 00814703016431: Tibial Insert, PS-Post, E-Link, Size 4, 11mm
• 00814703016424: Tibial Insert, PS-Post, E-Link, Size 4, 10mm
• 00814703016400: Tibial Insert, PS-Post, E-Link, Size 3, 16mm
• 00814703016394: Tibial Insert, PS-Post, E-Link, Size 3, 14mm
• 00814703016387: Tibial Insert, PS-Post, E-Link, Size 3, 13mm
• 00814703016370: Tibial Insert, PS-Post, E-Link, Size 3, 12mm
• 00814703016363: Tibial Insert, PS-Post, E-Link, Size 3, 11mm
• 00814703016356: Tibial Insert, PS-Post, E-Link, Size 3, 10mm
• 00814703016332: Tibial Insert, PS-Post, E-Link, Size 2, 16mm
• 00814703016325: Tibial Insert, PS-Post, E-Link, Size 2, 14mm
• 00814703016318: Tibial Insert, PS-Post, E-Link, Size 2, 13mm
• 00814703016301: Tibial Insert, PS-Post, E-Link, Size 2, 12mm
• 00814703016295: Tibial Insert, PS-Post, E-Link, Size 2, 11mm
• 00814703016288: Tibial Insert, PS-Post, E-Link, Size 2, 10mm
• 00814703016264: Tibial Insert, PS-Post, E-Link, Size 1, 16mm
• 00814703016257: Tibial Insert, PS-Post, E-Link, Size 1, 14mm
• 00814703016240: Tibial Insert, PS-Post, E-Link, Size 1, 13mm
• 00814703016233: Tibial Insert, PS-Post, E-Link, Size 1, 12mm
• 00814703016226: Tibial Insert, PS-Post, E-Link, Size 1, 11mm
• 00814703016219: Tibial Insert, PS-Post, E-Link, Size 1, 10mm